ID

15708

Beschrijving

Study For Patients With NSCLC EGFR Mutations (Del 19 or L858R +/- T790M); ODM derived from: https://clinicaltrials.gov/show/NCT02349633

Link

https://clinicaltrials.gov/show/NCT02349633

Trefwoorden

Versies (1)
  1. 09-06-16 09-06-16 -
Geüploaded op

9 juni 2016

DOI

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Creative Commons BY 4.0
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Eligibility Non-Small Cell Lung Cancer NCT02349633

Engels

Eligibility Non-Small Cell Lung Cancer NCT02349633

1 Formulieren  
Criteria
Beschrijving

Criteria

evidence of histologically or cytologically confirmed diagnosis of locally advanced or metastatic egfrm (del19 or l858r) nsclc that has progressed after at least 1 prior line of therapy.
Beschrijving

Non-Small Cell Lung Carcinoma Advanced Locally | Non-small cell lung cancer metastatic | EGFR gene mutation EGFR exon 19 deletion | EGFR gene mutation EGFR NP_005219.2:p.L858R | Therapeutic procedure | Disease Progression

Datatype

boolean

Alias
UMLS CUI [1,1]
C0007131
UMLS CUI [1,2]
C0205179
UMLS CUI [1,3]
C1517927
UMLS CUI [2]
C0278987
UMLS CUI [3,1]
C3266992
UMLS CUI [3,2]
C3889117
UMLS CUI [4,1]
C3266992
UMLS CUI [4,2]
C3274204
UMLS CUI [5]
C0087111
UMLS CUI [6]
C0242656
patients must have had disease progression on treatment with an approved egfr tki.
Beschrijving

Therapeutic procedure Epidermal Growth Factor Receptor | Disease Progression

Datatype

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0034802
UMLS CUI [2]
C0242656
in phase 1, patients may have also received other lines of therapy before or after the egfr tki.
Beschrijving

Phase I | Therapeutic procedure Other | Epidermal Growth Factor Receptor

Datatype

boolean

Alias
UMLS CUI [1]
C0282459
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C0205394
UMLS CUI [3]
C0034802
in phase 2, while patients may have had multiple lines of therapy, the last therapy prior to study treatment must have been an approved egfr tki and received within 6 weeks prior to study registration.
Beschrijving

Phase 2 | Therapeutic procedure Numerous | Epidermal Growth Factor Receptor

Datatype

boolean

Alias
UMLS CUI [1]
C0282460
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C0439064
UMLS CUI [3]
C0034802
in the phase 1 portion:
Beschrijving

Phase I Part

Datatype

boolean

Alias
UMLS CUI [1,1]
C0282459
UMLS CUI [1,2]
C0449719
in the dose escalation and mtd expansion portions patients must be t790m positive or unknown status.
Beschrijving

Dose Escalation | Maximum Tolerated Dose Increase | EGFR NP_005219.2:p.T790M Positive | EGFR NP_005219.2:p.T790M Unknown

Datatype

boolean

Alias
UMLS CUI [1]
C3816728
UMLS CUI [2,1]
C0752079
UMLS CUI [2,2]
C0442805
UMLS CUI [3,1]
C3274192
UMLS CUI [3,2]
C1446409
UMLS CUI [4,1]
C3274192
UMLS CUI [4,2]
C0439673
in the pk sub-studies, patients with egfrm (del 19 or l858r) with any t790m status are eligible to enroll.
Beschrijving

Pharmacokinetic study | EGFR gene mutation EGFR exon 19 deletion | EGFR gene mutation EGFR NP_005219.2:p.L858R | EGFR NP_005219.2:p.T790M Any status

Datatype

boolean

Alias
UMLS CUI [1]
C0201734
UMLS CUI [2,1]
C3266992
UMLS CUI [2,2]
C3889117
UMLS CUI [3,1]
C3266992
UMLS CUI [3,2]
C3274204
UMLS CUI [4,1]
C3274192
UMLS CUI [4,2]
C1549503
in the phase 2 portion:
Beschrijving

Phase 2 Part

Datatype

boolean

Alias
UMLS CUI [1,1]
C0282460
UMLS CUI [1,2]
C0449719
• patients must have egfrm (del 19 and t790m or l858r and t790m) nsclc tumors
Beschrijving

Non-Small Cell Lung Carcinoma | EGFR gene mutation EGFR exon 19 deletion EGFR NP_005219.2:p.T790M | EGFR gene mutation EGFR NP_005219.2:p.L858R EGFR NP_005219.2:p.T790M

Datatype

boolean

Alias
UMLS CUI [1]
C0007131
UMLS CUI [2,1]
C3266992
UMLS CUI [2,2]
C3889117
UMLS CUI [2,3]
C3274192
UMLS CUI [3,1]
C3266992
UMLS CUI [3,2]
C3274204
UMLS CUI [3,3]
C3274192
patients must have at least one measurable lesion as defined by recist version 1.1
Beschrijving

Measurable Disease

Datatype

boolean

Alias
UMLS CUI [1]
C1513041
tumor tissue available (ie, formalin fixed paraffin embedded (ffpe) block or 10 unstained sections (5 micron). an archival specimen is acceptable for phase 1; a de novo specimen is required for phase 2.
Beschrijving

Tumor tissue sample Availability | Formalin-fixed paraffin-embedded tissue specimen | Unstained Specimen

Datatype

boolean

Alias
UMLS CUI [1,1]
C0475358
UMLS CUI [1,2]
C0470187
UMLS CUI [2]
C2711483
UMLS CUI [3]
C1883469
patients must have adequate bone marrow, hepatic and renal functions
Beschrijving

Bone Marrow physiological aspects | Liver function | Renal function

Datatype

boolean

Alias
UMLS CUI [1,1]
C0005953
UMLS CUI [1,2]
C0031843
UMLS CUI [2]
C0232741
UMLS CUI [3]
C0232804
negative serum pregnancy test
Beschrijving

Serum pregnancy test negative

Datatype

boolean

Alias
UMLS CUI [1]
C0430061
exclusion criteria (partial list)
Beschrijving

Exclusion Criteria

Datatype

boolean

Alias
UMLS CUI [1]
C0680251
previously diagnosed brain metastases, unless the patient has completed their treatment and has recovered from the acute effects of radiation therapy or surgery prior to study registration, have discontinued corticosteroid treatment for these metastases for at least 2 weeks, and are neurologically stable.
Beschrijving

Metastatic malignant neoplasm to brain | Therapeutic radiology procedure | Operative Surgical Procedures | Steroid therapy Discontinued | Neurologic Stable status

Datatype

boolean

Alias
UMLS CUI [1]
C0220650
UMLS CUI [2]
C1522449
UMLS CUI [3]
C0543467
UMLS CUI [4,1]
C0149783
UMLS CUI [4,2]
C1444662
UMLS CUI [5,1]
C0205494
UMLS CUI [5,2]
C0205360
major surgery within 4 weeks prior to registration
Beschrijving

major surgery

Datatype

boolean

Alias
UMLS CUI [1]
C0679637
radiation therapy within 2 weeks prior to registration.
Beschrijving

Therapeutic radiology procedure

Datatype

boolean

Alias
UMLS CUI [1]
C1522449
systemic anti cancer therapy within 2 weeks or 5 half-lives (whichever is longer) of registration excluding egfr tkis. patients on egfr tkis must discontinue the agent for a minimum of 5 half-lives, or 5 days, whichever is longer, prior to registration
Beschrijving

cancer treatment Systemic | Epidermal Growth Factor Receptor

Datatype

boolean

Alias
UMLS CUI [1,1]
C0920425
UMLS CUI [1,2]
C0205373
UMLS CUI [2]
C0034802
concurrent use of drugs that are strong p-glycoprotein (p-gp) inhibitors (such as but not limited to: dronedarone, erythromycin, indinavir, indinavir/ritonavir, itraconazole, ketoconazole, lapatinib, lopinavir/ritonavir, quinidine, rifampin, ritonavir, valspodar, verapamil, vorapaxar). patients must avoid the use of drugs that are known strong p-gp inhibitors for the duration of the study. therapy with a t790m directed agent
Beschrijving

P-glycoprotein Inhibitor | dronedarone | Erythromycin | Indinavir | Indinavir+Ritonavir | Itraconazole | Ketoconazole | lapatinib | lopinavir / Ritonavir | Quinidine | Rifampin | Ritonavir | valspodar | Verapamil | vorapaxar | EGFR NP_005219.2:p.T790M Pharmacologic Substance

Datatype

boolean

Alias
UMLS CUI [1]
C3898062
UMLS CUI [2]
C0766326
UMLS CUI [3]
C0014806
UMLS CUI [4]
C0376637
UMLS CUI [5]
C1977393
UMLS CUI [6]
C0064113
UMLS CUI [7]
C0022625
UMLS CUI [8]
C1506770
UMLS CUI [9]
C0939237
UMLS CUI [10]
C0034414
UMLS CUI [11]
C0035608
UMLS CUI [12]
C0292818
UMLS CUI [13]
C0753474
UMLS CUI [14]
C0042523
UMLS CUI [15]
C2974521
UMLS CUI [16,1]
C3274192
UMLS CUI [16,2]
C1254351
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Similar models

Eligibility Non-Small Cell Lung Cancer NCT02349633

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Non-Small Cell Lung Carcinoma Advanced Locally | Non-small cell lung cancer metastatic | EGFR gene mutation EGFR exon 19 deletion | EGFR gene mutation EGFR NP_005219.2:p.L858R | Therapeutic procedure | Disease Progression
Item
evidence of histologically or cytologically confirmed diagnosis of locally advanced or metastatic egfrm (del19 or l858r) nsclc that has progressed after at least 1 prior line of therapy.
boolean
C0007131 (UMLS CUI [1,1])
C0205179 (UMLS CUI [1,2])
C1517927 (UMLS CUI [1,3])
C0278987 (UMLS CUI [2])
C3266992 (UMLS CUI [3,1])
C3889117 (UMLS CUI [3,2])
C3266992 (UMLS CUI [4,1])
C3274204 (UMLS CUI [4,2])
C0087111 (UMLS CUI [5])
C0242656 (UMLS CUI [6])
Therapeutic procedure Epidermal Growth Factor Receptor | Disease Progression
Item
patients must have had disease progression on treatment with an approved egfr tki.
boolean
C0087111 (UMLS CUI [1,1])
C0034802 (UMLS CUI [1,2])
C0242656 (UMLS CUI [2])
Phase I | Therapeutic procedure Other | Epidermal Growth Factor Receptor
Item
in phase 1, patients may have also received other lines of therapy before or after the egfr tki.
boolean
C0282459 (UMLS CUI [1])
C0087111 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
C0034802 (UMLS CUI [3])
Phase 2 | Therapeutic procedure Numerous | Epidermal Growth Factor Receptor
Item
in phase 2, while patients may have had multiple lines of therapy, the last therapy prior to study treatment must have been an approved egfr tki and received within 6 weeks prior to study registration.
boolean
C0282460 (UMLS CUI [1])
C0087111 (UMLS CUI [2,1])
C0439064 (UMLS CUI [2,2])
C0034802 (UMLS CUI [3])
Phase I Part
Item
in the phase 1 portion:
boolean
C0282459 (UMLS CUI [1,1])
C0449719 (UMLS CUI [1,2])
Dose Escalation | Maximum Tolerated Dose Increase | EGFR NP_005219.2:p.T790M Positive | EGFR NP_005219.2:p.T790M Unknown
Item
in the dose escalation and mtd expansion portions patients must be t790m positive or unknown status.
boolean
C3816728 (UMLS CUI [1])
C0752079 (UMLS CUI [2,1])
C0442805 (UMLS CUI [2,2])
C3274192 (UMLS CUI [3,1])
C1446409 (UMLS CUI [3,2])
C3274192 (UMLS CUI [4,1])
C0439673 (UMLS CUI [4,2])
Pharmacokinetic study | EGFR gene mutation EGFR exon 19 deletion | EGFR gene mutation EGFR NP_005219.2:p.L858R | EGFR NP_005219.2:p.T790M Any status
Item
in the pk sub-studies, patients with egfrm (del 19 or l858r) with any t790m status are eligible to enroll.
boolean
C0201734 (UMLS CUI [1])
C3266992 (UMLS CUI [2,1])
C3889117 (UMLS CUI [2,2])
C3266992 (UMLS CUI [3,1])
C3274204 (UMLS CUI [3,2])
C3274192 (UMLS CUI [4,1])
C1549503 (UMLS CUI [4,2])
Phase 2 Part
Item
in the phase 2 portion:
boolean
C0282460 (UMLS CUI [1,1])
C0449719 (UMLS CUI [1,2])
Non-Small Cell Lung Carcinoma | EGFR gene mutation EGFR exon 19 deletion EGFR NP_005219.2:p.T790M | EGFR gene mutation EGFR NP_005219.2:p.L858R EGFR NP_005219.2:p.T790M
Item
• patients must have egfrm (del 19 and t790m or l858r and t790m) nsclc tumors
boolean
C0007131 (UMLS CUI [1])
C3266992 (UMLS CUI [2,1])
C3889117 (UMLS CUI [2,2])
C3274192 (UMLS CUI [2,3])
C3266992 (UMLS CUI [3,1])
C3274204 (UMLS CUI [3,2])
C3274192 (UMLS CUI [3,3])
Measurable Disease
Item
patients must have at least one measurable lesion as defined by recist version 1.1
boolean
C1513041 (UMLS CUI [1])
Tumor tissue sample Availability | Formalin-fixed paraffin-embedded tissue specimen | Unstained Specimen
Item
tumor tissue available (ie, formalin fixed paraffin embedded (ffpe) block or 10 unstained sections (5 micron). an archival specimen is acceptable for phase 1; a de novo specimen is required for phase 2.
boolean
C0475358 (UMLS CUI [1,1])
C0470187 (UMLS CUI [1,2])
C2711483 (UMLS CUI [2])
C1883469 (UMLS CUI [3])
Bone Marrow physiological aspects | Liver function | Renal function
Item
patients must have adequate bone marrow, hepatic and renal functions
boolean
C0005953 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])
C0232741 (UMLS CUI [2])
C0232804 (UMLS CUI [3])
Serum pregnancy test negative
Item
negative serum pregnancy test
boolean
C0430061 (UMLS CUI [1])
Exclusion Criteria
Item
exclusion criteria (partial list)
boolean
C0680251 (UMLS CUI [1])
Metastatic malignant neoplasm to brain | Therapeutic radiology procedure | Operative Surgical Procedures | Steroid therapy Discontinued | Neurologic Stable status
Item
previously diagnosed brain metastases, unless the patient has completed their treatment and has recovered from the acute effects of radiation therapy or surgery prior to study registration, have discontinued corticosteroid treatment for these metastases for at least 2 weeks, and are neurologically stable.
boolean
C0220650 (UMLS CUI [1])
C1522449 (UMLS CUI [2])
C0543467 (UMLS CUI [3])
C0149783 (UMLS CUI [4,1])
C1444662 (UMLS CUI [4,2])
C0205494 (UMLS CUI [5,1])
C0205360 (UMLS CUI [5,2])
major surgery
Item
major surgery within 4 weeks prior to registration
boolean
C0679637 (UMLS CUI [1])
Therapeutic radiology procedure
Item
radiation therapy within 2 weeks prior to registration.
boolean
C1522449 (UMLS CUI [1])
cancer treatment Systemic | Epidermal Growth Factor Receptor
Item
systemic anti cancer therapy within 2 weeks or 5 half-lives (whichever is longer) of registration excluding egfr tkis. patients on egfr tkis must discontinue the agent for a minimum of 5 half-lives, or 5 days, whichever is longer, prior to registration
boolean
C0920425 (UMLS CUI [1,1])
C0205373 (UMLS CUI [1,2])
C0034802 (UMLS CUI [2])
P-glycoprotein Inhibitor | dronedarone | Erythromycin | Indinavir | Indinavir+Ritonavir | Itraconazole | Ketoconazole | lapatinib | lopinavir / Ritonavir | Quinidine | Rifampin | Ritonavir | valspodar | Verapamil | vorapaxar | EGFR NP_005219.2:p.T790M Pharmacologic Substance
Item
concurrent use of drugs that are strong p-glycoprotein (p-gp) inhibitors (such as but not limited to: dronedarone, erythromycin, indinavir, indinavir/ritonavir, itraconazole, ketoconazole, lapatinib, lopinavir/ritonavir, quinidine, rifampin, ritonavir, valspodar, verapamil, vorapaxar). patients must avoid the use of drugs that are known strong p-gp inhibitors for the duration of the study. therapy with a t790m directed agent
boolean
C3898062 (UMLS CUI [1])
C0766326 (UMLS CUI [2])
C0014806 (UMLS CUI [3])
C0376637 (UMLS CUI [4])
C1977393 (UMLS CUI [5])
C0064113 (UMLS CUI [6])
C0022625 (UMLS CUI [7])
C1506770 (UMLS CUI [8])
C0939237 (UMLS CUI [9])
C0034414 (UMLS CUI [10])
C0035608 (UMLS CUI [11])
C0292818 (UMLS CUI [12])
C0753474 (UMLS CUI [13])
C0042523 (UMLS CUI [14])
C2974521 (UMLS CUI [15])
C3274192 (UMLS CUI [16,1])
C1254351 (UMLS CUI [16,2])
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